Cystic Fibrosis Clinical Trial
OBJECTIVES: I. Determine the prevalence of nontuberculous mycobacteria in sputum cultures
from patients with cystic fibrosis.
II. Compare the clinical course of patients with negative versus positive cultures.
PROTOCOL OUTLINE: Participants are screened for nontuberculous mycobacteria (NTM) with 3
sputum acid-fast bacilli smears and mycobacterial cultures, with speciation of positive
cultures, collected over 1 year. Demographic data, diagnostic criteria, clinical
measurements, and other respiratory pathogen data are collected using the Cystic Fibrosis
Foundation Patient Registry Questionnaire.
NTM-positive patients (cases) matched with NTM-negative controls identified in screening are
followed every 3 months for 15 months. Cases are evaluated for NTM burden during the first 3
months.
Appropriate therapy is offered to consistently NTM-positive cases. Lung transplant
recipients are removed from study.
;
Primary Purpose: Screening, Time Perspective: Longitudinal
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